Covered stent
By setting a movable bottom support and a coating section at the bottom of the groove of the coating stent, a limiting groove is formed to limit the sheath core in the radial direction, the problem of traditional coating stents causing obstruction of branch blood flow, achieving better blood flow smoothness and smooth entry of branch stents.
Patent Information
- Application Number
- CN202311833531.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-12-27
- Publication Date
- 2025-06-27
- Estimated Expiration
- 2043-12-27
AI Technical Summary
Traditional coated stents may cause blood flow to the branched blood vessels after implantation, especially when the aorta is close to the branched blood vessels, the radial support force of the coating at the bottom of the groove is insufficient, causing the bottom of the groove to protrude, compressing the groove space, and blocking the guidewire or outer branch stent from entering the branch port.
A coating bracket is designed, and the bottom support is provided with a bottom support member at the bottom of the groove, including two supporting parts arranged at intervals along the width direction of the groove. The bottom coating section is located between the two supporting parts in the width direction. The support section can be movable relative to the bottom coating section, and a limiting groove is formed to limit the sheath core in the radial direction.
By reducing excessive bulge in the bottom area of the groove, the risk of obstruction of the guidewire or external branch stent entering the inner branch stent is reduced, ensuring that the blood flow of branch blood vessels can flow normally, and reducing complications caused by blood obstruction.
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Figure CN120203857A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular, to a covered stent. Background Art
[0002] Aortic aneurysm and aortic dissection are currently diseases that seriously endanger human life safety. If not actively treated, the aortic aneurysm and dissection will continue to grow and finally rupture, causing serious complications and death. With the continuous increase in the number of patients with hypertension, hyperlipidemia, and hyperglycemia, the current incidence of aortic aneurysm and aortic dissection is also increasing significantly.
[0003] Traditional open surgery for treating aortic aneurysm and aortic dissection has the disadvantages of large trauma, high mortality, long operation time, high incidence of postoperative complications, and high operation difficulty. Endovascular treatment surgery has the characteristics of small trauma, few postoperative complications, short operation time, and low operation difficulty, and has gradually become the main method for treating aortic aneurysm and aortic dissection currently. The endovascular treatment surgery implants a stent into the aorta through a delivery device, isolates the vascular lesion outside the stent, and restricts the blood flow to flow through the inside of the stent, so as to achieve the purpose of protecting the blood vessel.
[0004] When the aneurysm or arterial dissection is located at a position on the aorta close to the branch vessel, the implanted stent may block the opening of the branch vessel, resulting in blocked blood flow in the branch vessel. One of the current methods to solve this problem is to provide a groove on the stent. The inner wall of the groove is provided with a branch opening communicating with the inner cavity of the stent. The groove corresponds to the branch vessel to ensure that the blood in the aorta enters the branch vessel through the groove. A film is usually provided at the bottom of the groove. However, due to the insufficient radial support force of the film at the bottom of the groove, after the stent is implanted into the blood vessel, if the pressure in the inner cavity of the stent is relatively large, the bottom of the groove will bulge and compress the space of the groove, thereby hindering the guide wire or the external branch stent from entering the branch opening. Summary of the Invention
[0005] In view of the above-mentioned deficiencies, the present invention provides a covered stent.
[0006] An embodiment of the present invention provides a covered stent, including:
[0007] A main body stent, provided with a groove, and the bottom of the groove of the groove includes a bottom film;
[0008] A support structure, including a bottom support member, and the bottom support member is used to support the bottom film;
[0009] Wherein, the bottom support member includes two support portions spaced apart along the width direction of the groove, the bottom film includes a blank bottom film section, and the bottom film section is located between the two support portions along the width direction of the groove; the two support portions can move relative to each other so that the bottom film section can be deformed.
[0010] In the film-covered stent according to an embodiment of the present invention, the two support portions can move relative to each other so that the bottom film section can be deformed to form a limiting groove for axially limiting the sheath core along the radial direction. The extension dimension of the bottom film section in the width direction of the groove is greater than half of the circumference of the sheath core, and the extension dimension of the bottom film section in the width direction of the groove is greater than or less than the circumference of the sheath core.
[0011] In the film-covered stent according to an embodiment of the present invention, the film-covered stent includes a plurality of bottom support members sequentially arranged in the axial direction, namely a first bottom support member, a second bottom support member, and a third bottom support member; at least two of the first bottom support member, the second bottom support member, and the third bottom support member respectively correspond to include the two support portions and the bottom film section.
[0012] In the film-covered stent according to an embodiment of the present invention, the film-covered stent includes two inner branch stents arranged side by side in the radial direction within the main body stent, namely a first branch stent and a second branch stent. One end of the first branch stent facing the groove is provided with a first branch opening, and one end of the second branch stent facing the groove is provided with a second branch opening. The edges of the first branch opening and the second branch opening connected to the bottom of the groove form a raised gap bulging upward, and the bottom film section and the raised gap are arranged opposite to each other in the axial direction.
[0013] In the film-covered stent according to an embodiment of the present invention, the bottom film section axially penetrates the bottom support member.
[0014] In the film-covered stent according to an embodiment of the present invention, the bottom support member further includes:
[0015] A joint portion, the joint portion is respectively connected to the two support portions. One of the support portions and the other support portion are arranged side by side along the width direction of the groove to form a spaced space. The area of the bottom film corresponding to the spaced space is the bottom film section. The joint portion and the bottom film section are arranged side by side in the axial direction, and the joint portion is closer to the axial end of the bottom film than the bottom film section.
[0016] In the film-covered stent according to an embodiment of the present invention, the film-covered stent includes: the joint portion and the support portion are movably connected, and the movable connection includes one or more of hook connection, hinge connection, and connection through an elastic member.
[0017] In the covered stent according to an embodiment of the present invention, the support portion includes a plurality of support sub-units arranged in sequence in the width direction of the groove, and the support sub-unit closest to the bottom covered segment in the support portion is indirectly connected to the joint portion.
[0018] In the covered stent according to an embodiment of the present invention, the covered stent further includes an inner branch stent disposed in the main body stent, the inner branch stent communicates with the inner cavity of the main body stent and the groove, and at least one of the inner branch stents is disposed on one axial side of the groove; the bottom support member at the axial end of the bottom of the groove includes a width reduction section, and the width of the width reduction section becomes smaller in the direction close to the inner branch stent.
[0019] In the covered stent according to an embodiment of the present invention, the support portion includes:
[0020] A net structure, including a first radial side edge and a second radial side edge spaced apart in the width direction of the groove, and the first radial side edge is closer to the bottom covered segment than the second radial side edge;
[0021] Support units, extending axially and connected to the first radial side edge of the net structure;
[0022] A deformable buffer unit, connected to the second radial side edge of the net structure.
[0023] An embodiment of the present invention further provides a covered stent, including:
[0024] A main body stent, provided with a groove;
[0025] A limiting structure, including a limiting member and a constraining member, the limiting member is detachably connected to the constraining member; when the covered stent is in a first state, the limiting member can be used to limit a target segment of the sheath core in the radial direction under the constraint of the constraining member, the target segment is an axial section of the sheath core, and the target segment is located in the axial region between the proximal end and the distal end of the groove in the first state; when the covered stent is in a second state, the constraining member can be disengaged from the limiting member so that the limiting member releases the restriction on the target segment.
[0026] An embodiment of the present invention further provides a covered stent, including:
[0027] A main body stent, provided with a groove;
[0028] Two inner branch stents, the two inner branch stents are arranged side by side in the radial direction in the main body stent, the inner branch stents are provided with branch openings facing the groove, and the branch openings communicate with the groove;
[0029] The limiting channel is formed between the two inner branch stents and is used to radially limit the sheath core.
[0030] In the covered stent provided by the embodiment of the present invention, since the bottom support member includes two support portions arranged at a radial interval, the bottom covering film includes a blank bottom covering film section, and the bottom covering film section is located radially between the two support portions; the two support portions can move relative to each other so that the bottom covering film section can be deformed. Such a setting of the bottom support member can reduce or avoid the excessive bulging of the bottom area of the groove where the bottom support member is located towards the opening direction of the groove, thereby occupying too much space of the groove, and thus reducing the risk that the bottom of the groove blocks the guide wire or the outer branch stent from entering the inner branch stent.
[0031] When the covered stent located in the target cavity is released and deployed from the delivery device, the sheath core of the delivery device abuts against the supra-aortic region of the aortic arch, and the covered stent expands in a direction away from the sheath core. Since the limiting channel can radially limit the sheath core before the covered stent is fully deployed, the probability of the sheath core deviating relative to the groove can be reduced, so that the groove of the covered stent can be more accurately aligned with the branch blood vessel after implantation, reducing the probability of the covered stent blocking or occluding the branch blood vessel, and further ensuring that the blood flow in the branch blood vessel can flow normally and smoothly, and reducing the complications caused by poor blood flow.
[0032] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit the disclosure of the embodiments of the present invention. Description of the Drawings
[0033] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.
[0034] Figure 1 It is a schematic diagram of the implanted state of the covered stent provided by an embodiment of the present invention;
[0035] Figure 2 It is a schematic structural diagram of the covered stent provided by an embodiment of the present invention;
[0036] Figure 3 It is a partial structural diagram of the covered stent provided by an embodiment of the present invention;
[0037] Figure 4 It is a partial structural diagram of the covered stent provided by an embodiment of the present invention;
[0038] Figure 5 It is a schematic structural diagram of the covered stent provided by an embodiment of the present invention;
[0039] Figure 6 It is a partial structural schematic diagram of a covered stent provided by an embodiment of the present invention;
[0040] Figure 7 It is a structural schematic diagram of a covered stent provided by an embodiment of the present invention;
[0041] Figure 8 It is a structural schematic diagram of a covered stent provided by an embodiment of the present invention, in which the sheath core penetrates through the covered stent;
[0042] Figure 9 It is a partial structural schematic diagram of a covered stent provided by an embodiment of the present invention, which shows the bottom film and the support structure;
[0043] Figure 10 It is a cross-sectional schematic diagram of a covered stent provided by an embodiment of the present invention, which shows the limiting groove;
[0044] Figure 11 It is a partial structural schematic diagram of a covered stent provided by an embodiment of the present invention, which shows the bottom film and the support structure;
[0045] Figure 12(A) is a partial structural schematic diagram of a covered stent provided by an embodiment of the present invention;
[0046] Figure 12(B) is a partial structural schematic diagram of a covered stent provided by an embodiment of the present invention;
[0047] Figure 13 It is a partial structural schematic diagram of a support structure provided by an embodiment of the present invention;
[0048] Figure 14 It is a partial structural schematic diagram of a bottom support provided by an embodiment of the present invention;
[0049] Figure 15 It is a structural schematic diagram of a covered stent provided by an embodiment of the present invention, in which the sheath core penetrates through the covered stent;
[0050] Figure 16 is Figure 15 a partial structural schematic diagram in;
[0051] Figure 17(A) is Figure 15 a partial structural schematic diagram in;
[0052] Figure 17(B) is a connection schematic diagram of the limiting member 91 and the outer sheath tube of the conveyor provided by an embodiment of the present invention;
[0053] Figure 18 It is a structural schematic diagram of a limiting member provided by an embodiment of the present invention;
[0054] Figure 19 It is a schematic structural diagram of a first limiting part provided by an embodiment of the present invention;
[0055] Figure 20(A) is a schematic structural diagram of a second limiting part provided by an embodiment of the present invention;
[0056] Figure 20(B) is a schematic structural diagram of a second limiting part provided by an embodiment of the present invention;
[0057] Figure 21 It is a schematic structural diagram of a covered stent provided by an embodiment of the present invention, wherein a sheath core penetrates through the covered stent;
[0058] Figure 22 It is a partial schematic structural diagram of a covered stent provided by an embodiment of the present invention;
[0059] Figure 23 It is a partial schematic structural diagram of a covered stent provided by an embodiment of the present invention;
[0060] Figure 24 It is a partial schematic structural diagram of a covered stent provided by an embodiment of the present invention;
[0061] Figure 25 It is a partial schematic structural diagram of a covered stent provided by an embodiment of the present invention;
[0062] Figure 26 It is a partial schematic structural diagram of a covered stent provided by an embodiment of the present invention;
[0063] Figure 27 It is a partial schematic structural diagram of a covered stent provided by an embodiment of the present invention;
[0064] Figure 28 It is a partial schematic structural diagram of a covered stent provided by an embodiment of the present invention, which shows a limiting channel and an end support;
[0065] Figure 29 It is a partial schematic structural diagram of a covered stent provided by an embodiment of the present invention, which shows a limiting channel and an end support. Detailed implementation manners
[0066] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, rather than all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.
[0067] In the description of the present invention, it should be understood that the orientation or positional relationship indicated by the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of the said features. In the description of the present invention, "a plurality" means two or more, unless otherwise specifically defined.
[0069] It should also be understood that the terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention. As used in the specification of the present invention and the appended claims, unless the context clearly indicates otherwise, the singular forms "a", "an" and "the" are intended to include the plural forms.
[0070] It should be further understood that the term "and / or" used in the specification of the present invention and the appended claims refers to any combination and all possible combinations of one or more of the associated listed items, and includes these combinations.
[0071] The following will describe in detail some embodiments of the present invention with reference to the drawings. Without conflict, the following embodiments and the features in the embodiments may be combined with each other.
[0072] For the convenience of description, the terms "proximal end" and "distal end" are defined herein as the commonly used terms in the field of interventional medicine. Specifically, the "distal end" represents the end where blood flows out, and the "proximal end" represents the end where blood flows in. For example, after a stent is implanted into a lumen, blood flows from the proximal end to the distal end of the stent; the "axial direction" represents its length direction, or the direction in which the interventional device is advanced and withdrawn; the "radial direction" represents the direction perpendicular to the "axial direction".
[0073] Taking a blood vessel as an example to illustrate the lumen, the blood vessel may include at least one of the following: aortic arch, thoracic aorta, abdominal aorta, etc. Those of ordinary skill in the art should be aware that using a blood vessel for illustration is only for example and not a limitation of the present invention. The solution of the present invention is applicable to various human lumens or other biological lumens. For example, human lumens may include digestive tract lumens or blood vessels, etc. All improvements and deformations based on the teachings of the present invention are within the protection scope of the present invention.
[0074] The "wave loop" in the embodiments of the present invention includes multiple waves, and the "waveform unit" includes at least one wave. Among them, the "wave loop" (also known as the waveform ring structure) is a closed or non-closed waveform ring structure. Both the wave loop and the waveform unit can be arranged on the inner wall and / or outer wall of the film of the covered stent. The wave loop or the waveform unit can be connected to the film by at least one of the following connection methods: suture, bonding, hot melting, etc. The "wave loop" and the "waveform unit" are made by weaving or cutting a metal elastic material, a polymer material or other biocompatible elastic materials. The metal elastic material includes known materials implanted in medical devices or combinations of various biocompatible materials, such as alloys of two or more single metals among cobalt, chromium, nickel, titanium, magnesium, iron, and 316L stainless steel, nickel-titanium-tantalum alloy, etc., or other biocompatible metal elastic materials. The polymer material includes biocompatible materials such as polylactic acid. Both the "wave loop" and the "waveform unit" have radial expansion ability, can achieve radial contraction under external force, and self-expand or expand mechanically (for example, expand by balloon dilation) after the external force is withdrawn to restore to the initial shape and maintain the initial shape. Therefore, after being implanted into the lumen, it can closely adhere to the inner wall of the lumen through its radial supporting force. The waveforms of the waves in the "wave loop" and the "waveform unit" are not limited, including Z-shaped waves, M-shaped waves, V-shaped waves, sine waves, etc. Both the "wave loop" and the "waveform unit" include wave peaks, wave valleys, and wave rods connecting adjacent wave peaks and wave valleys. Among them, one vertex (wave peak or wave valley) and the two wave rods connected to the vertex form a wave.
[0075] The "support structure" in an embodiment of the present invention can be connected to the bottom film by at least one of the following connection methods: suture, bonding, hot melting, etc. The support structure can be arranged on the inner wall and / or outer wall of the bottom film of the covered stent. The support structure can include waveform units and / or mesh structures, etc. The support structure is made by weaving or cutting a metal elastic material, a polymer material or other biocompatible elastic materials. The metal elastic material includes known materials implanted in medical devices or combinations of various biocompatible materials, such as alloys of two or more single metals among cobalt, chromium, nickel, titanium, magnesium, iron, and 316L stainless steel, nickel-titanium-tantalum alloy, etc., or other biocompatible metal elastic materials. The polymer material includes biocompatible materials such as polylactic acid.
[0076] The "film coating" in the embodiments of the present invention can isolate liquid to a certain extent, and it can be made of at least one polymer material with good biocompatibility such as polytetrafluoroethylene (abbreviated as PTFE) and polyethylene terephthalate (abbreviated as PET).
[0077] Please refer to Figure 1 , the embodiments of the present invention provide a film-coated stent 100 for implanting into a target cavity. The above target cavity can be any cavity in a living body, and the present invention does not limit the type of the target cavity. For the convenience of understanding, the aortic arch 300 is taken as an example of the target cavity in the present invention. Referring to Figure 1 , the aortic arch 300 is connected with three branch vessels 200. The branch vessels 200 are connected to the large curvature side of the aortic arch 300, and blood flows from the aortic arch 300 to the branch vessels 200. An aneurysm 400 is formed on the small curvature side of the aortic arch 300 (only for illustrative purposes, in other embodiments, the aneurysm 400 may be distributed at other positions of the aortic arch 300). By implanting the film-coated stent 100 into the aortic arch 300 to isolate the aneurysm 400, the blood flowing in the film-coated stent 100 cannot contact the aneurysm 400, and finally the purpose of treating the aneurysm 400 is achieved. An outer branch stent 500 can also be implanted in the three branch vessels 200. The outer branch stent 500 can be connected to the film-coated stent 100, and the blood in the film-coated stent 100 enters the branch vessels 200 through the outer branch stent 500.
[0078] Please refer to Figure 1 and Figure 2 , in some embodiments, the film-coated stent 100 is integrally a hollow tubular structure with openings at both ends. The film-coated stent 100 includes a main stent 10. Exemplarily, the main stent 10 includes a main film coating 11 and a stent main body 12. The stent main body 12 can be disposed on the inner surface and / or outer surface of the main film coating 11. The main film coating 11 can completely cover the stent main body 12 or partially cover the stent main body 12. Exemplarily, the stent main body 12 includes at least one support corrugated ring for supporting the main film coating 11.
[0079] Exemplarily, the main body film 11 can be a single-layer structure or a multi-layer structure, which is not limited herein. The main body film 11 can be made of at least one of the following materials: polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and other polymer materials with good biocompatibility. The main body film 11 can be fixed on the inner surface and / or outer surface of the stent main body 12 by means of suture, adhesion, heat fusion, etc., so as to play roles such as reconstructing the fluid channel and isolating the diseased area of the blood vessel.
[0080] Please refer to Figure 1 and Figure 2 , in some embodiments, the main body stent 10 can be axially divided into a distal segment 1, a proximal segment 2, and an intermediate segment 3. The intermediate segment 3 is located between the proximal segment 2 and the distal segment 1; the proximal segment 2 includes a tubular proximal stent 2a and a proximal main body film 11a. The proximal main body film 11a can be covered on the inner surface and / or outer surface of the proximal stent 2a by means of suture, adhesion, heat fusion, etc. The proximal stent 2a includes a plurality of main body wave loops 101 arranged at axial intervals; the distal segment 1 includes a tubular distal stent 1a and a distal main body film 11b. The distal stent 1a includes a plurality of main body wave loops 101 arranged at axial intervals. The distal main body film 11b can also be covered on the inner surface and / or outer surface of the distal stent 1a by means of suture, adhesion, heat fusion, etc. The intermediate segment 3 includes an intermediate main body film 11c and an intermediate stent 3a. The intermediate stent 3a includes a plurality of arc-shaped waveform units arranged at axial intervals. The intermediate main body film 11c can be covered on the inner surface and / or outer surface of the intermediate stent 3a by means of suture, adhesion, heat fusion, etc. The inner cavity formed by enclosing the intermediate main body film 11c is communicated with the inner cavity formed by enclosing the proximal main body film 11a and the inner cavity formed by enclosing the distal main body film 11b.
[0081] Please also refer to Figure 2 and Figure 3, in some embodiments, the main body stent 10 is provided with a groove 5. Exemplarily, the main body stent 10 is recessed towards its inner cavity on the side of the middle section 3 to form a groove 5. The groove 5 includes a groove bottom 51 and a groove opening 52. Among them, the groove opening 52 and the groove bottom 51 are oppositely arranged in the radial direction of the covered stent 100, and the groove opening 52 faces the radial outside of the covered stent 100, while the groove bottom 51 is closer to the inner cavity of the main body stent 10 as a whole than the groove opening 52. In some embodiments, the edge formed by the groove 5 on the main body covering film 11 is generally rectangular, that is, when the main body covering film 11 is unfolded along the generatrix not passing through the groove 5, the groove 5 is generally rectangular. The groove 5 includes a first edge 531, a second edge 532, a third edge 533 and a fourth edge 534. Among them, the first edge 531 and the second edge 532 are oppositely arranged in the radial direction (or oppositely arranged in the width direction of the groove 5) and are consistent with the length extension direction of the covered stent 100. The third edge 533 and the fourth edge 534 are oppositely arranged in the axial direction and are closer to the end of the covered stent 100 than the first edge 531 and the second edge 532. It can be understood that in other embodiments, the groove 5 can also be other shapes, as long as the first edge 531 and the second edge 532 generally extend along the length extension direction of the covered stent 100. For example, it can form a certain angle with the length extension direction of the covered stent 100 (such as the groove 5 is trapezoidal), or the first edge 531 and the second edge 532 are arc-shaped (such as the groove 5 is similar to an ellipse). The present invention does not limit the specific shape of the groove 5. In other embodiments, the groove 5 can also be an annular recessed structure surrounding the main body stent 10. It can also be understood that the groove 5 is located between the proximal end and the distal end of the covered stent 100. The groove 5 can be closer to the proximal end of the covered stent 100, or closer to the distal end of the covered stent 100, or the distance from the proximal end of the covered stent 100 is equal to the distance from the distal end of the covered stent 100.
[0082] Please refer to Figure 2 and Figure 3, in some embodiments, the covered stent 100 is further provided with an inner branch stent 8, and the inner branch stent 8 includes a tubular branch covering 801. The number of the inner branch stents 8 can be designed according to actual needs, such as one, two, three or more. At least one inner branch stent 8 is arranged on one axial side of the groove 5. In some embodiments, a plurality of inner branch stents 8 are provided, and the inner branch stents 8 are located in the inner cavity of the main stent 10 and are respectively arranged on the proximal side and the distal side of the groove 5. For example, the inner branch stent 8 is arranged in the main stent 10, the inner branch stent 8 is connected to the inner wall of the main stent 10, and the inner branch stent 8 extends along the length direction of the main stent 10. The inner cavity of the inner branch stent 8 communicates with the inner cavity of the main stent 10 and the groove 5. When an outer branch stent 500 needs to be implanted into the branch blood vessel 200, one end of the outer branch stent 500 can be sleeved with the inner branch stent 8, and the other end extends to the corresponding branch blood vessel 200 through the groove 5, so as to form a channel for blood to flow from the main stent 10 to the branch blood vessel 200. In this embodiment, branch support members can also be arranged on the branch covering 801 of the inner branch stent 8 to better maintain the shape of the inner branch stent 8.
[0083] Please refer to Figure 2 , in some embodiments, a mesh cover 61 is further arranged outside the groove 5. The two circumferential sides of the mesh cover 61 are fixedly connected to the middle main body covering 11c by means of sewing, bonding, hot melting, etc., and at least a part of the mesh cover 61 forms a gap (or void, cavity, interval) with the bottom 51 of the groove 5 in the radial direction of the covered stent 100, and this gap can communicate with the inner cavity of the inner branch stent 8. Exemplarily, the mesh cover 61 is in an arc structure in the circumferential direction and is integrally woven into a mesh structure by knitting wires; the central angle corresponding to the projection of the mesh cover 61 on the radial plane is less than or equal to 120 degrees, so that the mesh cover 61 has good radial support force and ensures that there is enough space in the main stent 10 for blood flow to pass through. In other embodiments, the above-mentioned mesh cover 61 can be omitted.
[0084] Please refer to Figure 3 and Figure 4, exemplarily, the bottom 51 of the groove includes a bottom film 51a, through which the inner cavity of the main body stent 10 can be radially isolated from the groove 5. Exemplarily, the first edge 531 and the second edge 532 of the groove 5 are respectively connected to the two radial sides (also referred to as the two sides in the width direction, or the two transverse sides) of the bottom film 51a, and the third edge 533 and the fourth edge 534 of the groove 5 are respectively connected to the two axial ends of the bottom film 51a. Each inner branch stent 8 includes two branch openings, one of which is closer to the groove 5 than the other. The branch opening closer to the groove 5 is connected to the bottom 51 of the groove. Among them, the branch opening closer to the groove 5 includes an upper edge and a lower edge, the upper edge of which is connected to the inner wall of the main body stent 10, and the lower edge of which can be sutured, bonded or integrally formed with the bottom film 51a.
[0085] Please refer to Figure 4 , exemplarily, two inner branch stents 8 are provided in the inner cavity of the proximal section 2 of the main body stent 10, denoted as the first branch stent 81 and the second branch stent 82 respectively. The first branch stent 81 and the second branch stent 82 are arranged side by side in the radial direction on the proximal side of the groove 5. The end of the first branch stent 81 closer to the groove 5 (i.e., the distal end of the first branch stent 81) is provided with a first branch opening 811, and the end of the second branch stent 82 closer to the groove 5 (i.e., the distal end of the second branch stent 82) is provided with a second branch opening 821. Both the first branch opening 811 and the second branch opening 821 face the groove 5. The proximal ends of the first branch stent 81 and the second branch stent 82 are also provided with branch openings, and these branch openings all face the proximal end of the main body stent 10. One inner branch stent 8 is provided in the inner cavity of the distal section 1 of the main body stent 10, denoted as the third branch stent 83. The third branch stent 83 is arranged on the distal side of the groove 5. The end of the third branch stent 83 closer to the groove 5 (i.e., the proximal end of the third branch stent 83) is provided with a third branch opening 831, and this third branch opening 831 faces the groove 5. The distal end of the third branch stent 83 is also provided with a branch opening, and this branch opening faces the distal end of the main body stent 10.
[0086] Please refer to Figure 5, in some embodiments, the covered stent 100 includes a first branch stent 81 and a second branch stent 82. The first branch stent 81 is disposed within the main body stent 10 and communicates with the groove 5. The second branch stent 82 is connected to the main body stent 10. One end of the second branch stent 82 is fixedly connected to and communicates with the main body stent 10, and the other end is a free end and has a branch opening. The free end of the second branch stent 82 is disposed outside the main body stent 10 for implantation into the branch blood vessel 200 or connection with other stents. The length extension direction of the second branch stent 82 intersects the axial direction; both the second branch stent 82 and the first branch stent 81 communicate with the inner cavity of the main body stent 10. After the second branch stent 82 communicates with the corresponding branch blood vessel 200, the groove 5 of the covered stent 100 is aligned with the opening of the other branch blood vessel 200, which can reduce the situation that it is difficult for the groove 5 to be aligned with the corresponding branch blood vessel 200 due to the deflection of the covered stent 100 after release; in addition, by disposing the free end of the second branch stent 82 outside the main body stent 10, the second branch stent 82 can be implanted into the branch blood vessel 200 without occupying the space of the inner cavity of the main body stent 10, thereby reducing the occupation of the inner cavity of the main body stent 10 by the branch stent and increasing the blood flow in the inner cavity of the main body stent 10; compared with the first branch stent 81 and the second branch stent 82 being arranged side by side in the radial direction within the main body stent 10, in this embodiment, disposing the free end of the second branch stent 82 outside the main body stent 10 can also enable the guide wire or the outer branch stent 500 to enter the corresponding branch stent more accurately and reduce the risk of the guide wire accidentally entering another branch stent. Exemplarily, the length extension direction of the second branch stent 82 is perpendicular to the axial direction.
[0087] Please refer to Figure 5 and Figure 6 , in some embodiments, the first branch stent 81 is disposed within the main body stent 10, and the first branch stent 81 communicates with the groove 5; the second branch stent 82 and the first branch stent 81 are disposed on one side of the axial direction of the groove 5. Exemplarily, the second branch stent 82 and the first branch stent 81 are disposed on the side where the proximal end of the groove 5 is located, that is, both the second branch stent 82 and the first branch stent 81 are disposed in the proximal segment 2 of the main body stent 10. If the first branch stent 81 and the second branch stent 82 are arranged side by side in the radial direction on the side where the proximal end of the groove 5 is located, a triangular area is formed by enclosing the part of the first branch stent 81 adjacent to the second branch stent 82, the part of the second branch stent 82 adjacent to the first branch stent 81, and the inner wall of the main body stent 10. The triangular area will form a vortex under the impact of blood flow, thereby affecting the blood flow direction in the inner cavity of the main body stent 10. In this embodiment, by disposing the second branch stent 82 outside the main body stent 10, the first branch stent 81 and the second branch stent 82 on one side of the axial direction of the groove 5 will not form a triangular area with the main body stent 10, so the influence on the blood flow direction in the inner cavity of the main body stent 10 can be reduced.
[0088] Please refer to Figure 5 , in some embodiments, a guiding section 812 is formed at the distal end of the first branch stent 81, and the cross-sectional area of the guiding section 812 extends from the proximal end to the distal end in a gradually increasing manner. The distal end of the first branch stent 81 is designed as a flared guiding section 812, and the guiding section 812 can guide the entry of a guide wire or an outer branch stent 500.
[0089] Please refer to Figure 7 , exemplarily, the proximal end of the covered stent 100 is the upper end, and the distal end of the covered stent 100 is the lower end. The second branch stent 82 is disposed on the right side of the first branch stent 81 to better adapt to the three branch vessels 200 near the aortic arch 300. The second branch stent 82 is used for implanting Figure 1 into the leftmost one of the branch vessels 200. After the second branch stent 82 is implanted into the corresponding branch vessel 200, it can, to a certain extent, position the covered stent 100 so that the groove 5 is aligned with the other two branch vessels 200; after the second branch stent 82 is implanted into the corresponding branch vessel 200, the second branch stent 82 will not interfere with the implantation of the other two branch vessels 200 with the corresponding outer branch stents 500, nor will it interfere with the connection between the outer branch stent 500 and the corresponding inner branch stent 8.
[0090] In some embodiments, the first branch stent 81 can also be disposed outside the main stent 10. For example, one end of the first branch stent 81 is fixedly connected and communicated with the main stent 10, the other end is a free end and has a branch opening, and the free end of the first branch stent 81 is disposed outside the main stent 10. The length extension direction of the first branch stent 81 intersects the axial direction. The first branch stent 81 and the second branch stent 82 are arranged along the axial direction of the groove stent 100 and are disposed on the proximal section 2. That is, the first branch stent 81 and the second branch stent 82 are respectively used to communicate with two branch vessels 200. After the first branch stent 81 and the second branch stent 82 communicate with the corresponding branch vessels 200, the groove 5 of the covered stent 100 is aligned with the openings of the other branch vessels 200, which can effectively reduce the situation that it is difficult for the groove 5 to be aligned with the corresponding branch vessels 200 due to the easy deflection of the covered stent 100 during release; in addition, by disposing the branch openings at the free ends of the first branch stent 81 and the second branch stent 82 outside the main stent 10, the first branch stent 81 and the second branch stent 82 can be implanted into the branch vessels 200 without occupying the space of the inner cavity of the main stent 10, thereby further reducing the occupation of the inner cavity of the main stent 10 by the branch stents and further increasing the blood flow in the inner cavity of the main stent 10. In other embodiments, the covered stent 100 further includes a third branch stent 83, and the third branch stent 83 is disposed on the distal side of the groove 5. The third branch stent 83 is disposed outside the main stent 10; or, the third branch stent 83 is disposed inside the inner cavity of the main stent 10.
[0091] In other embodiments, the first branch stent 81 and the second branch stent 82 may also be disposed at the distal end of the groove 5, and the third branch stent 83 is disposed at the proximal end of the groove 5. In other embodiments, one or more of the first branch stent 81, the second branch stent 82, and the third branch stent 83 may be omitted.
[0092] Exemplarily, an annular support member (not shown in the figure) is provided at the edge of each branch stent to better maintain the shape of the branch opening, and the annular support member can be made of a radiopaque material, which can provide a support function and can be visualized during the operation to better indicate the position of the branch opening.
[0093] Please refer to Figure 8 , in some embodiments, the covered stent 100 includes a support structure 7, and the support structure 7 includes a bottom support member 71, and the bottom support member 71 is used to support the bottom 51 of the groove 5. Exemplarily, the bottom 51 of the groove includes a bottom film 51a, and the bottom support member 71 is used to support the bottom film 51a. The setting of the bottom support member 71 is beneficial to better maintain the shape of the inner cavity of the main stent 10 and / or the bottom 51 of the groove, and can reduce or avoid the excessive bulge of the bottom area of the groove where the bottom support member 71 is located toward the groove opening 52 direction, so as to avoid occupying too much space of the groove 5. Therefore, the risk that the bottom 51 of the groove blocks the guide wire or the outer branch stent 500 from entering the inner branch stent 8 can be reduced; in addition, it can also maintain sufficient inner cavity space for the main stent 10.
[0094] Please refer to Figure 9 and Figure 10 , in some embodiments, the bottom support member 71 includes two support portions 711 spaced along the width direction of the bottom 51 of the groove (or the radial direction, the width direction of the groove 5), and the bottom film 51a includes a blank bottom film section 511. The blank bottom film section 511 means that this area only includes the film and does not include other support structures. In the width direction of the bottom 51 of the groove, the bottom film section 511 is located between the two support portions 711; the two support portions 711 can move relative to each other so that the bottom film section 511 can be deformed. Such a setting enables the bottom support member 71 to reduce or avoid the excessive bulge of the bottom area of the groove where the bottom support member 71 is located toward the groove opening 52 direction, so as to avoid occupying too much space of the groove 5, thereby reducing the risk that the bottom 51 of the groove blocks the guide wire or the outer branch stent 500 from entering the inner branch stent 8; at the same time, it can also enable the bottom support member 71 to maintain good lateral bending performance (that is, the performance of bending toward the radial side of the groove 5), so that the covered stent 100 can well adapt to the curved shape of the blood vessel and better fit the blood vessel wall.
[0095] In some embodiments, the two supporting portions 711 can move relative to each other so that the bottom film-covered section 511 can be deformed to form a limiting groove 51 for radially limiting the sheath core 600. In actual application of the film-covered stent 100 of this embodiment, the film-covered stent 100 can be first compressively assembled in a conveyor (such as compressed into a delivery sheath). When the film-covered stent 100 is compressed in the conveyor, since the two supporting portions 711 of the film-covered stent 100 can move relative to each other, the blank bottom film-covered section 511 can be deformed to form a limiting groove 512, and at least a part of the sheath core 600 of the conveyor can be received in the limiting groove 512, so that the limiting groove 512 can hinder the displacement of the sheath core 600 in the radial direction to a certain extent. For example, the limiting groove 512 can radially limit the sheath core 600. If the above-mentioned limiting groove 512 is not provided, when the film-covered stent 100 is compressively assembled into the conveyor, the sheath core 600 of the conveyor may be radially offset outside the area where the groove 5 is located; during the implantation process of the film-covered stent 100, after the conveyor (including the sheath core 600) enters the aortic arch 300, it will abut against the supra-arch region 301, so that during the release process of the film-covered stent 100, it can only expand in the direction away from the sheath core 600. If the sheath core is radially offset outside the area where the groove 5 is located during assembly, after the film-covered stent 100 is released, its groove 5 will also deviate from the supra-arch region 301 accordingly. The branch vessels 200 connected to the aortic arch 300 are usually located near the supra-arch region 301. If the released position of the groove 5 deviates far from the supra-arch region 301, it may cause the groove 5 to be difficult to align with the branch vessels 200, resulting in the film-covered stent 100 blocking the opening of the branch vessels 200, and further causing the blood flow of the branch vessels 200 to be blocked. Since the limiting groove 512 formed by the bottom film-covered section 511 of the film-covered stent 100 of this embodiment can hinder the displacement of the sheath core 600 in the radial direction to a certain extent before the release of the film-covered stent 100, during the process of withdrawing the sheath of the film-covered stent 100, the sheath core 600 can be manually placed at the position where the limiting groove 512 is located to reduce the probability of the sheath core 600 deviating relative to the groove 5. Thus, after the film-covered stent 100 is released, its groove 5 can more accurately align with the branch vessels 200, reducing the probability of the film-covered stent 100 blocking or clogging the branch vessels 200, and further ensuring that the blood flow of the branch vessels 200 can flow normally and smoothly, reducing the complications caused by poor blood flow. After the film-covered stent 100 is implanted into the target cavity and released from the conveyor, the bottom film-covered section 511 naturally unfolds, and the bottom film-covered section 511 releases the radial limitation on the sheath core 600, that is, the bottom film-covered section 511 does not form a limiting groove 512 for radially limiting the sheath core 600. Therefore, when the sheath core 600 is withdrawn from the target cavity, the sheath core 600 will not pull the bottom of the groove 51, resulting in damage or even breakage of the bottom film 51a.
[0096] Exemplarily, when the covered stent 100 is loaded in the conveyor, the sheath core 600 can pass through the inner cavity of the middle section 3. At this time, the bottom covered section 511 forms a limiting groove 512 that bulges toward the direction of the groove opening 52 to radially limit the sheath core 600; alternatively, the sheath core 600 can also be located outside the inner cavity of the middle section 3. The sheath core 600 enters the proximal section 2 through the groove 5. At this time, the bottom covered section 511 forms a limiting groove 512 that is recessed toward the direction away from the groove opening 52 (i.e., bulges toward the inner cavity direction of the main stent 10) to radially limit the sheath core 600.
[0097] It can be understood that the regions corresponding to the two supporting parts 711 in the covered stent 100 are the first region 50a and the second region 50b respectively. The first region 50a, the bottom covered section 511, and the second region 50b are arranged along the width direction of the groove bottom 51. The two radial side edges of the bottom covered section 511 (i.e., the side edges in the width direction of the bottom covered section 511) are respectively connected to the first region 50a and the second region 50b. The blank bottom covered section 511 means that no supporting corrugated rings, corrugated units, or supporting wires and other supporting structures are provided on the bottom covered section 511. Therefore, the radial supporting force of the bottom covered section 511 is less than that of the first region 50a and the second region 50b on both sides. When being radially squeezed, the first region 50a and the second region 50b where the two supporting parts 711 are located can move relative to each other, such as approaching or moving away from each other, so that the bottom covered section 511 can be deformed to form a limiting groove 512 for radially limiting the sheath core 600. Exemplarily, the two supporting parts 711 arranged at intervals in the radial direction (i.e., along the width direction of the groove bottom 51) are respectively denoted as the first supporting part 711a and the second supporting part 711b.
[0098] The number of the bottom supports 71 can be set according to actual requirements, such as one, two, three, or more. Please refer to Figure 9, in some embodiments, the covered stent 100 includes three bottom supports 71 arranged axially in sequence, namely a first bottom support 71a, a second bottom support 71b, and a third bottom support 71c. In this embodiment, the first bottom support 71a is disposed in the proximal region of the bottom of the groove 51, the third bottom support 71c is disposed in the distal region of the bottom of the groove 51, and the second bottom support 71b is disposed between the proximal region and the distal region of the bottom of the groove 51. In other embodiments, the relative positions between the first bottom support 71a, the second bottom support 71b, and the third bottom support 71c can also be designed as other positional relationships according to actual needs. For example, the third bottom support 71c is disposed in the proximal region of the bottom of the groove 51, and the first bottom support 71a is disposed in the distal region of the bottom of the groove 51, etc. The number of the first bottom support 71a, the second bottom support 71b, and the third bottom support 71c can all be designed according to actual requirements. For example, they can all be one, two, three, or more. Exemplarily, the number of the first bottom support 71a is one, the number of the second bottom support 71b includes at least two, the number of the third bottom support 71c is one, and one first bottom support 71a, two second bottom supports 71b, and one third bottom support 71c are arranged axially.
[0099] It can be understood that the covered stent 100 includes a plurality of bottom supports 71 arranged axially. The adjacent bottom supports 71 can be connected or not connected. Exemplarily, the plurality of bottom supports 71 are sequentially arranged at intervals from the proximal end to the distal end, so that the bottom of the groove 51 can be bent in segments, enabling the bottom of the groove 51 to have good bending flexibility and lateral bending performance, which is beneficial for the bottom of the groove 51 to better conform to the lateral bending of the covered stent 100, enabling the bottom of the groove 51 and the covered stent 100 to better adapt to the lateral bending shape of the blood vessel, improving the wall attachment of the covered stent 100, and reducing the risk of blood leakage and thrombus formation.
[0100] In some embodiments, at least one of the first bottom support member 71a, the second bottom support member 71b, and the third bottom support member 71c respectively includes two support portions 711 and a bottom film covering section 511, so that the bottom film covering 51a can form a limiting groove 512, thereby radially limiting the sheath core 600. Exemplarily, at least two of the first bottom support member 71a, the second bottom support member 71b, and the third bottom support member 71c respectively include two support portions 711 and a bottom film covering section 511 to improve the radial limiting ability of the sheath core 600. For example, the first bottom support member 71a and the second bottom support member 71b respectively include two support portions 711 and a bottom film covering section 511, and the third bottom support member 71c is an integral structure. There is no blank bottom film covering section 511 in the radial region where the third bottom support member 71c is located, that is, there are no two parts spaced apart by the bottom film covering section 511 in the middle of the third bottom support member 71c along the width direction of the groove bottom 51. Another example is that the first bottom support member 71a and the third bottom support member 71c respectively include two support portions 711 and a bottom film covering section 511, and the second bottom support member 71b is an integral structure. There is no blank bottom film covering section 511 in the radial region where the second bottom support member 71b is located, that is, there are no two parts spaced apart by the bottom film covering section 511 in the middle of the second bottom support member 71b along the width direction of the groove bottom 51. Still another example is that the second bottom support member 71b and the third bottom support member 71c respectively include two support portions 711 and a bottom film covering section 511, and the first bottom support member 71a is an integral structure. There is no blank bottom film covering section 511 in the radial region where the first bottom support member 71a is located, that is, there are no two parts spaced apart by the bottom film covering section 511 in the middle of the first bottom support member 71a along the width direction of the groove bottom 51.
[0101] In other embodiments, the bottom film covering section 511 may be provided only on the second bottom support member 71b, and not on the first bottom support member 71a and the third bottom support member 71c located at the ends. The second bottom support member 71b located in the middle region can more flexibly respond to the action of the radial force to form the limiting groove 512.
[0102] Please refer to Figure 11, in some embodiments, the first bottom support 71a, the second bottom support 71b, and the third bottom support 71c each include two support portions 711 spaced apart along the width direction of the bottom of the groove 51, and a bottom film segment 511 is provided between the two support portions 711. Exemplarily, the two support portions 711 of the first bottom support 71a are spaced apart along the width direction of the bottom of the groove 51, and a bottom film segment 511 is provided between the two support portions 711 of the first bottom support 71a, denoted as the first film segment 511a; the two support portions 711 of the first bottom support 71a can move relative to each other so that the first film segment 511a can deform and form a limiting groove 512 for radially limiting the sheath core 600. The two support portions 711 of the second bottom support 71b are spaced apart along the width direction of the bottom of the groove 51, and a bottom film segment 511 is provided between the two support portions 711 of the second bottom support 71b, denoted as the second film segment 511b; the two support portions 711 of the second bottom support 71b can move relative to each other so that the second film segment 511b can deform and form a limiting groove 512 for radially limiting the sheath core 600. The two support portions 711 of the third bottom support 71c are spaced apart along the width direction of the bottom of the groove 51, and a bottom film segment 511 is provided between the two support portions 711 of the third bottom support 71c, denoted as the third film segment 511c; the two support portions 711 of the third bottom support 71c can move relative to each other so that the bottom film segment 511c can deform and form a limiting groove 512 for radially limiting the sheath core 600. The first film segment 511a, the second film segment 511b, and the third film segment 511c are arranged along the conveying direction of the sheath core 600, and the first film segment 511a, the second film segment 511b, and the third film segment 511c can respectively form a limiting groove 512 for radially limiting the sheath core 600, thereby improving the radial limiting ability of the sheath core 600, effectively reducing the probability of the sheath core 600 deviating relative to the groove 5, and reducing the probability of the covered stent 100 blocking or occluding the branch vessel 200.
[0103] In some embodiments, the extension dimension (or width, radial extension dimension) of the bottom film covering section 511 in the width direction of the bottom of the groove 51 is greater than half of the circumference of the sheath core 600. The bottom film covering section 511 can radially wrap more than half of the circumference of the sheath core 600, that is, the groove wall of the limiting groove 512 can radially wrap more than half of the circumference of the sheath core 600 to ensure better constraint of the sheath core 600. If the radial extension length of the bottom film covering section 511 is exactly equal to the circumference of the sheath core 600 and still wraps the sheath core 600 after the film covering stent 100 is implanted into the target lumen, under the action of the radial extrusion force of the target lumen on the film covering stent 100, if the two support portions 711 located on both sides of the bottom film covering section 511 exactly abut against each other, it may be difficult to withdraw the sheath core 600 (not impossible to withdraw, but the limiting groove 512 has a strong radial constraint on the sheath core 600 and is difficult to withdraw radially, so it is recommended to withdraw along the axial direction). For this reason, exemplarily, the extension dimension of the bottom film covering section 511 in the width direction of the bottom of the groove 51 may be greater than half of the circumference of the sheath core 600, but not equal to the circumference of the sheath core 600. For example, the extension dimension of the bottom film covering section 511 in the width direction of the bottom of the groove 51 is greater than or less than the circumference of the sheath core 600, so that on the basis of ensuring a good constraint and limiting effect on the sheath core 600, the sheath core 600 can be more easily withdrawn from the limiting groove 512 after the film covering stent 100 is released. In other embodiments, the extension dimension of the bottom film covering section 511 in the width direction of the bottom of the groove 51 may also be equal to the circumference of the sheath core 600; or, the extension dimension of the bottom film covering section 511 in the width direction of the bottom of the groove 51 may also be less than half of the circumference of the sheath core 600.
[0104] In some embodiments, the inner branch stent 8 includes a branch opening facing the groove 5. The bottom film covering section 511 is axially opposite to the branch opening. The extension dimension of the bottom film covering section 511 in the width direction of the bottom of the groove 51 may be less than the diameter of the branch opening. Since the extension dimension of the bottom film covering section 511 in the width direction of the bottom of the groove 51 is less than the diameter of the branch opening, even if the bottom film covering section 511 is relatively close to the branch opening and the bottom film covering 51a and the support structure 7 are radially extruded, causing the bottom film covering section 511 to deform and form the limiting groove 512, the bottom film covering section 511 is not likely to bulge and completely block the branch opening or block the guide wire or the outer branch stent 500 from entering the branch opening, and can ensure that the guide wire or the outer branch stent 500 can smoothly enter the inner branch stent 8 on the premise that the bottom film covering section 511 forms the limiting groove 512 for radially limiting the sheath core 600.
[0105] Referring to FIG. 12(A), in some embodiments, the edges of the first branch port 811 and the second branch port 821 connected to the bottom of the groove 51 form a raised gap 54 that bulges upward, and the bottom film covering section 511 is axially opposed to the raised gap 54. The edges of both the first branch port 811 and the second branch port 821 connected to the bottom of the groove 51 (e.g., connected to the bottom film 51a) form a shape similar to a slightly curved "W", and the sharp corner position of the middle bulge of the "W" shape forms the raised gap 54 that bulges upward (i.e., in the direction towards the upper edges of the first branch port 811 and the second branch port 821). When the bottom of the groove 51 is subjected to a radial squeezing force, the upwardly raised gap 54 can cooperate with the bottom film covering section 511 to achieve a better limiting effect on the sheath core 600.
[0106] In addition, please also refer to Figure 9 , when the bottom film covering section 511 is provided on the first bottom support member 71a in the proximal region of the bottom of the groove 51, and the bottom film covering section 511 axially penetrates the first bottom support member 71a and is axially opposed to and connected to the raised gap 54. After the film covering stent 100 is implanted, under the radial squeezing action of the target lumen, the upwardly raised gap 54 can guide the bottom film covering section 511 to bulge upward accordingly, playing a certain guiding role near the branch port, and the bottom film covering sections 511 provided on both radial sides of the bottom film covering section 511 can well maintain the shape of the bottom film 51a in the regions near the first branch port 811 and the second branch port 821. The bottom film 51a in the regions near the first branch port 811 and the second branch port 821 is not likely to bulge or deform irregularly after the film covering stent 100 is implanted into the target lumen, causing blockage of the branch port. The bottom support members 71 at both axial ends of the bottom of the groove 51 can maintain a certain distance from the branch port, and the range of this distance is 1 mm to 3 mm; such a setting is beneficial for the raised gap 54 to better guide the bottom film covering section 511 to bulge upward when the groove 5 is subjected to radial squeezing, and at the same time, it can also avoid the bottom support member 71 deforming axially and elongating to abut against the annular support member at the branch port during the radial compression process due to too small a distance, making it difficult to continue radial contraction and deformation. It can be understood that in other embodiments, the annular support member can be omitted, and the distance between the bottom support members 71 at both axial ends of the bottom of the groove 51 and the branch port can be less than 1 mm, or even the two are in contact with each other.
[0107] Please refer to FIGS. 12(A) and 12(B). In some embodiments, the bottom support member 71 further includes a coupling portion 712. The coupling portion 712 is respectively connected to the first support portion 711a and the second support portion 711b. The first support portion 711a and the second support portion 711b are arranged along the width direction of the bottom of the groove 51 and form a spaced-apart space 713. The region of the bottom film 51a corresponding to the spaced-apart space 713 is the bottom film section 511, that is, the coupling portion 712 and the bottom film section 511 are arranged axially. The coupling portion 712 is closer to the axial end of the bottom of the groove 51 relative to the bottom film section 511. The setting of the coupling portion 712 is beneficial to improving the radial support ability of the bottom support member 71 near the branch opening, and can better maintain the shape of the connection between the bottom of the groove 51 and the branch opening of the inner branch stent 8. In addition, when subjected to radial extrusion, the bottom film section 511 can deform to form a limiting groove 512, so that the bottom of the groove 51 can limit the sheath core 600. Exemplarily, please refer to FIG. 12(B). The coupling portion 712 includes overlapping waveform units 712a and waveform units 712b. The radial ends of the waveform unit 712a are respectively connected to the radial ends of the waveform unit 712b, and the waveform unit 712a and the waveform unit 712b have opposite phases, so as to form a plurality of support sub-units arranged in sequence in the radial direction. For example, a first grid, and the first grid can be a quadrilateral mesh such as a rhombus or a quasi-rhombus, or any other suitable shape. The coupling portion 712 and the support portion 711 can be movably connected. For example, the waveform unit 712a, the waveform unit 712b are movably connected to the first support portion 711a and the second support portion 711b (for example, hooked connection to each other), so that a certain degree of relative movement can occur axially at the connection between the coupling portion 712 and the support portion 711. Such a setting enables the coupling portion 712 and the support portion 711 to deform relatively independently. Therefore, when the bottom support member 71 is located at the axial end of the groove 5, even if a large extrusion force is applied between the support portions 711, they can deform relatively independently without directly causing a large deformation of the coupling portion 712, and the coupling portion 712 can still well maintain the shape of the bottom film 51a near the branch opening.
[0108] Please refer to FIG. 12(B). The first support portion 711a includes a plurality of support sub-units arranged in sequence in the radial direction. For example, the support sub-units of the first support portion 711a are the second grid. The second support portion 711b includes a plurality of support sub-units arranged in sequence in the radial direction. For example, the support sub-units of the second support portion 711b are the third grid. The support sub-unit of the first support portion 711a closest to the bottom film covering section 511 and the support sub-unit of the second support portion 711b closest to the bottom film covering section 511 are not directly connected to the joint portion 712. For example, they are not directly hooked to the joint portion 712, but are only connected thereto through the blank film covering. Such an arrangement is beneficial in that when the bottom support member 71 is under pressure, the support sub-units of the first support portion 711a and the second support portion 711b closest to the bottom film covering section 511 can more flexibly cause the bottom film covering section 511 to deform and form the limiting groove 512. It can be understood that in other embodiments, the grids in the joint portion 712 and / or the support portion 711 can be replaced by one or more waves protruding towards the axial end of the groove 5, or any other suitable structure can be used as the support sub-unit. In other embodiments, the joint portion 712 and the support portion 711 can also be movably connected in other ways. For example, the joint portion 712 and the support portion 711 are only connected through the blank bottom film covering section, or are hinged, and can also be movably connected by means of elastic members (such as springs, elastic wires), etc. In other embodiments, the joint portion 712 can be movably connected to only one support portion 711, and relative independent deformation between the two can also be achieved to a certain extent. In other embodiments, the joint portion 712 and the support portion 711 may not adopt a movable connection.
[0109] Please refer to Figure 13, in some embodiments, the support portion 711 includes a mesh structure 714 and a support unit 715. Exemplarily, the mesh structure 714 and the support unit 715 can be integrally woven by support wires made of a metal or other medical material with shape memory function. In other embodiments, the mesh structure 714 and the support unit 715 can also be integrally cut. The mesh structure 714 includes a first radially side edge and a second radially side edge that are spaced along the width direction of the bottom of the groove 51. The first radially side edge is closer to the bottom film section 511 than the second radially side edge; the width of the axially end portion of the mesh structure 714 closer to the branch port is smaller than the maximum width of the mesh structure 714. In other embodiments, the width of the mesh structure 714 can remain consistent. The support unit 715 extends axially, and the support unit 715 is connected to the first radially side edge of the mesh structure 714. Exemplarily, the support unit 715 includes multiple axially support wires 7151 arranged in sequence axially. The adjacent two axially support wires 7151 overlap and / or are hooked at the intersection. When subjected to radial extrusion, the bottom film section 511 can form a limiting groove 512, and the support unit 715 can support the notch of the limiting groove 512, so that the bottom film section 511 can better wrap at least part of the sheath core 600, and further enable the limiting groove 512 formed by the bottom film section 511 to effectively limit the sheath core 600.
[0110] Please refer to Figure 14 , in some embodiments, the bottom support 71 includes multiple columns of cross units and deformable mesh holes 7143 formed by the overlapping of multiple first-direction support wires 7141 arranged at intervals and multiple second-direction support wires 7142 arranged at intervals. Each axially support wire 7151 and the corresponding first-direction support wire 7141 and / or second-direction support wire 7142 in the mesh structure 714 are of an integral structure and form an edge bending angle at the first radially edge of the mesh structure 714. The edge bending angle is an acute angle, and the supplementary angle of the edge bending angle is greater than the inner angle of the deformable mesh hole 7143 in the mesh structure 714. Exemplarily, please refer to Figure 13 and Figure 14, the support unit 715 includes a first axially supporting wire 7151a and a second axially supporting wire 7151b. The first axially supporting wire 7151a and the second axially supporting wire 7151b extend substantially axially (substantially axially extending means that the angle with the axis of the covered stent 100 does not exceed 10°). The proximal end of the first axially supporting wire 7151a is connected to a first-direction supporting wire 7141 (denoted as the first wire 7141a), and the distal end of the first axially supporting wire 7151a is connected to a second-direction supporting wire 7142 (denoted as the second wire 7142a). The first wire 7141a, the first axially supporting wire 7151a, and the second wire 7142a are of an integral structure. The first wire 7141a and the first axially supporting wire 7151a form a first edge bending angle α, and the second wire 7142a and the first axially supporting wire 7151a form a second edge bending angle β. Both the first edge bending angle α and the second edge bending angle β are acute angles. The supplementary angle of the first edge bending angle α is equal to 180° - α, and the supplementary angle of the second edge bending angle β is equal to 180° - β. The supplementary angles of the first edge bending angle α and the second edge bending angle β are both greater than the interior angle within the deformable mesh hole 7143 in the mesh structure 714. The relative relationship between the second axially supporting wire 7151b and the corresponding first-direction supporting wire 7141 and second-direction supporting wire 7142 is the same and will not be elaborated here. Without the axially supporting wire 7151, the radial edge of the mesh structure 714 near the bottom covering section 511 or a row of deformable mesh holes 7143 directly faces the bottom covering section 511. After the covered stent 100 is implanted, it will conform to the blood vessel bending and be affected by the impact of blood and the pulsation of the blood vessel. The angle of the sharp corner of the radial edge of the mesh structure 714 or the deformable mesh hole 7143 facing the bottom covering section 511 is too small, which may wear or pierce the bottom covering section 511. The supplementary angle of the edge bending angle is greater than the interior angle of the deformable mesh hole 7143 in the mesh structure 714, which can reduce the risk of the sharp corner at the edge of the mesh structure 714 wearing and piercing the covering film.
[0111] Please refer to Figure 13 and Figure 14, in some embodiments, the bottom support 71 further includes a deformable buffer unit 716 at the radial edge, and the buffer unit 716 is connected to the mesh structure 714. For example, in this embodiment, each of the two radial edges of the first bottom support 71a and the third bottom support 71c includes a buffer unit 716; in other embodiments, only one radial edge of the bottom support 71 includes a buffer unit 716, or two or more buffer units 716 can be provided on each radial edge of the bottom support 71. In other embodiments, the above buffer unit 716 can be omitted. Since the buffer unit 716 is radially close to the radial edge of the groove 5, when the groove 5 is subjected to radial pressure, the buffer unit 716 is first subjected to force and deforms and moves, rather than immediately transmitting the force to the mesh structure 714, thereby playing a certain buffering role, being able to better maintain the overall shape of the bottom support 71, preventing the blockage of the branch port, and being beneficial to maintaining the shape of the bottom of the groove 51. Exemplarily, the buffer unit 716 includes a buffer rod 7161 and a connecting rod 7162. One end of the connecting rod 7162 is connected to the mesh structure 714, and the other end of the connecting rod 7162 is connected to the buffer rod 7161. The buffer rod 7161 is located at the radial edge of the bottom support 71, and the buffer rod 7161 is closer to the radial edge of the bottom support 71 than the connecting rod 7162. A buffer vertex 7163 is formed at the connection between the buffer rod 7161 and the connecting rod 7162, and a movable gap is formed between the buffer vertex 7163 and the mesh structure 714, so that the buffer vertex 7163 can move relative to the mesh structure 714, which is beneficial to improving the buffering effect of the buffer unit 716. The above buffer rod 7161 can be used to connect to the bottom film 51a at this position, and can preferentially deform under the action of radial force to buffer the radial force, and then conduct the force that cannot be buffered to the connecting rod 7162, and the connecting rod 7162 moves to further buffer the radial force. In this embodiment, the buffer rod 7161 is substantially parallel to the radial edge of the groove 5, which is beneficial to its uniform force in the radial direction and can play a buffering role more sensitively and efficiently. In other embodiments, the buffer rod 7161 can be arranged at an angle, for example, an acute angle with the radial edge of the groove 5. Figure 14 The number of buffer rods 7161 in the buffer unit 716 is one, and a triangle or a quasi-triangle is formed by enclosing between the buffer rod 7161 and the connecting rod 7162. In other embodiments, the number of buffer units 716 can be multiple, and a quadrilateral or other polygon is formed by enclosing between multiple buffer rods 7161 and the connecting rod 7162. And when there are multiple buffer rods 7161, buffer vertices 7163 can also be formed at the connections of the mutually connected buffer rods 7161. It can be understood that the bottom support 71 in Fig. 12(B) and Figure 13 , Figure 14Although the structures of the bottom support member 71 in [reference] are different, the bottom support member 71 in FIG. 12(B) may also include a buffer unit 716.
[0112] Please refer to Figure 13 , in some embodiments, the bottom support member 71 located at the axial end of the bottom of the groove 51 includes a width reduction section X, which is located at the bottom of the groove 51 and whose width becomes smaller in the direction close to the inner branch bracket 8, so that the area of the bottom support member 71 close to the branch opening forms a trapezoid-like structure. For example, at least one of the first bottom support member 71a and the third bottom support member 71c includes a width reduction section X, the maximum radial dimension D2 (or width) of the first bottom support member 71a is greater than the radial dimension D1 of the proximal end of the first bottom support member 71a, and the maximum radial dimension of the third bottom support member 71c may be greater than the radial dimension of the distal end of the third bottom support member 71c. The purpose of this structure is that when the covered stent 100 is implanted and the bottom of the groove 51 is radially squeezed by the target cavity, the area where the bottom of the groove 51 is connected to the branch opening can form a trapezoid-like guiding structure following the width reduction section X, which can better guide the guide wire and the outer branch bracket 500 into the branch opening.
[0113] Exemplarily, the structures of the first bottom support member 71a, the second bottom support member 71b, and the third bottom support member 71c are different; in other embodiments, at least two of the first bottom support member 71a, the second bottom support member 71b, and the third bottom support member 71c may also have the same structure. For example, please refer to Figure 13 , in combination with Figure 9 , both the first bottom support member 71a and the third bottom support member 71c include a mesh structure 714, and the mesh structures 714 of the first bottom support member 71a and the third bottom support member 71c may be the same or different. Another example, please refer to Figure 13 , the second bottom support member 71b includes a first corrugated unit 7101 and a second corrugated unit 7102, and the first corrugated unit 7101 and the second corrugated unit 7102 are arranged in an overlapping and / or hooked manner. Exemplarily, the peaks of the first corrugated unit 7101 and the valleys of the second corrugated unit 7102 are axially opposite to each other.
[0114] Please refer to Figures 15 to 17(A), in some embodiments, the covered stent 100 includes the main stent 10 of any of the above embodiments and a limiting structure 9. The limiting structure 9 includes a limiting member 91 and a constraining member 92 for constraining the position of the limiting member 91. The limiting member 91 is detachably connected to the constraining member 92. When the covered stent 100 is in the first state, the limiting member 91 can be used to radially limit the target section 601 of the sheath core 600 under the constraint of the constraining member 92. The target section 601 is an axial section of the sheath core 600, and this axial region is located within the axial region between the proximal end and the distal end of the groove 5 (i.e., within the axial region of the middle section 3) in the first state. When the covered stent 100 is in the second state, the constraining member 92 can be detached from the limiting member 91 so that the limiting member 91 releases the restriction on the target section 601.
[0115] For the covered stent 100 of the above embodiments, when the covered stent 100 is in the first state (such as the compressed state when compressed and assembled in the sheath of the delivery device), the limiting member 91 of the limiting structure 9 can be used to radially limit the target section 601 of the sheath core 600 under the constraint of the constraining member 92. When it is necessary to implant the covered stent 100 into the target cavity, the covered stent 100 is implanted into the target cavity through the delivery device. When the covered stent 100 located in the target cavity is released and deployed from the delivery device, the target section 601 of the sheath core 600 of the delivery device abuts against the supra-aortic region 301 of the aortic arch 300, and the covered stent 100 expands in a direction away from the target section 601 of the sheath core 600. Since the limiting member 91 can radially limit the sheath core 600 under the constraint of the constraining member 92 before the covered stent 100 is fully deployed, the probability of the sheath core 600 deviating from the bottom of the groove 5 (such as the bottom film 51a) can be reduced. As a result, after the covered stent 100 is implanted, its groove 5 can more accurately align with the branch vessel, reducing the probability of the covered stent 100 blocking or occluding the branch vessel 200, and thus ensuring that the blood flow in the branch vessel 200 can flow normally and smoothly, reducing complications caused by poor blood flow. When the covered stent 100 is in the second state, the constraining member 92 can be detached from the limiting member 91 so that the limiting member 91 releases the restriction on the target section 601, so that when the sheath core 600 is withdrawn from the target cavity, the sheath core 600 will not pull the bottom of the groove 51, resulting in damage or even breakage of the bottom film.
[0116] Exemplarily, the first state is the compressed state corresponding to the covered stent 100 being compressed and assembled in the delivery device, and the second state is the fully deployed state corresponding to the covered stent 100 being implanted into the target cavity and released from the sheath of the delivery device. In other embodiments, the first state can also be a semi-deployed state between the compressed state and the fully deployed state, and the second state is the fully deployed state; or, the first state is the compressed state corresponding to the covered stent 100 being compressed and assembled in the delivery device, and the second state is a semi-deployed state between the compressed state and the fully deployed state.
[0117] In some embodiments, the restraint member 92 includes a restraint wire. When the covered stent 100 is in the first state, the restraint wire can pass through the limiting member 91 so that the limiting member 91 can be used to limit the target segment 601 in the radial direction; when the covered stent 100 is in the second state, the restraint member 92 can move axially so that the restraint wire disengages from the limiting member 91, thereby enabling the limiting member 91 to release the restriction on the target segment 601. The diameter of the restraint wire is small, resulting in less trauma to the organism when implanting the covered stent 100 into the target cavity. Exemplarily, one end of the restraint wire is used to enter the target cavity together with the main body stent 10, and the other end of the restraint wire can extend out of the organism having the target cavity to facilitate withdrawing the restraint wire outward, so that the restraint wire disengages from the limiting member 91, thereby enabling the limiting member 91 to release the restriction on the target segment 601. In other embodiments, both ends of the restraint wire can enter the target cavity together with the main body stent 10, and the restraint wire can be connected to the sheath core 600 or other components of the delivery device other than the sheath core 600. When the sheath core 600 or the delivery device is withdrawn, the restraint wire can be withdrawn together with the sheath core 600 or the delivery device.
[0118] The number of the limiting members 91 can be set according to actual needs, such as one, two, three or more. For example, the number of the limiting members 91 is two, and the two limiting members 91 are arranged at intervals along the axial direction to improve the radial limiting effect on the target segment 601.
[0119] Please refer to Figure 16 and FIG. 17(A). In some embodiments, the limiting member 91 includes a limiting wire 911, and the end of the limiting wire 911 can form a wire buckle portion 912. When the covered stent 100 is in the first state, the restraint member 92 can pass through the wire buckle portion 912 so that the limiting wire 911 can cooperate with the inner wall of the inner cavity of the main body stent to limit the target segment 601; when the covered stent 100 is in the second state, the restraint member 92 can be withdrawn from the wire buckle portion 912 so that the limiting wire 911 releases the restriction on the target segment 601. The limiting member 91 with this structure is simple in structure and light in weight. Exemplarily, both the limiting wire 911 and the restraint wire are made of materials with biocompatibility and little damage to the organism. Exemplarily, when the covered stent 100 is in the first state, one of the target segment 601 and the wire buckle portion 912 is located in the inner cavity of the main body stent 10, and the other is located in the groove 5. For example, when the covered stent 100 is in the first state, the target segment 601 is located in the inner cavity of the main body stent 10, and the wire buckle portion 912 is located in the groove 5.
[0120] Please refer to FIG. 17(A). In some embodiments, the wire buckle portion 912 includes a first wire buckle 9121 and a second wire buckle 9122. The first wire buckle 9121 can be formed at one end of the limiting wire 911; the second wire buckle 9122 can be formed at the other end of the limiting wire 911. When the covered stent 100 is in the first state, the restraining member 92 can pass through the first wire buckle 9121 and the second wire buckle 9122, so that the limiting wire 911 can cooperate with the target section 601 of the main stent for limiting; when the covered stent 100 is in the second state, the restraining member 92 can be disengaged from the first wire buckle 9121 and the second wire buckle 9122, so that the limiting wire 911 releases the restriction on the sheath core 600. When it is necessary to assemble the covered stent 100 to the conveyor, the restraining member 92 can be passed through the first wire buckle 9121 and the second wire buckle 9122, so that the limiting wire 911 can bind the target section 601 to a preset area, thereby realizing the radial limitation of the sheath core 600; when the covered stent 100 is implanted into the target cavity and released from the conveyor, the restraining member 92 can be moved along the withdrawal direction by means of the conveyor or other instruments or directly operating the restraining member 92, so that the restraining member 92 is disengaged from the first wire buckle 9121 and the second wire buckle 9122. At this time, the two ends of the limiting wire 911 are no longer restricted by the restraining member 92, and the binding of the limiting wire 911 to the target section 601 is weakened or even released, providing a guarantee for the sheath core 600 to be smoothly removed from the target cavity. The first wire buckle 9121 and the second wire buckle 9122 can restrain and limit the sheath core 600 at two different positions in the axial direction or the conveying direction of the sheath core 600, improving the reliability and stability of the radial limitation of the sheath core 600 when the covered stent 100 is in the first state. Exemplarily, when the covered stent 100 is in the first state, the limiting wire 911 penetrates through the bottom film 51a, so that the sheath core 600 passes through the inner cavity of the middle section 3 (please refer to Figure 2 ), and the wire buckle portion 912 is located in the other of the inner cavity of the middle section 3 and the groove 5. In other embodiments, one of the first wire buckle 9121 and the second wire buckle 9122 can also be omitted.
[0121] Please refer to FIG. 17 (B). Exemplarily, the limiting wire 911 can be connected to the sheath core 600. The sheath core 600 is inserted into one of the inner cavity and the groove 5 of the main support 10, and the wire buckle portion 912 is located in the other of the inner cavity and the groove 5 of the middle section 3. Exemplarily, the number of limiting wires 911 includes two, and each limiting wire 911 is fixedly connected to the sheath core 600. For example, the limiting wire 911 includes a connecting section 9123, one end of which is fixedly connected to the sheath core 600 by bonding or the like, and the other end can penetrate the bottom coating 51a and form a wire buckle portion 912 for the constraint 92 to pass through. In other embodiments, the connecting section 9123 can be detachably connected to the sheath core 600. For example, a connecting wire is provided on the sheath core 600, and the connecting wire and the limiting wire 911 are connected to each other by a slipknot. In other embodiments, the number of the limiting lines 911 can be designed to be other numbers according to actual needs, such as one, three or more.
[0122] See also Figure 18 In some embodiments, the limiting member 91 includes a first limiting portion 913 and a second limiting portion 914. When the stent graft 100 is in the first state, the constraint member 92 passes through the first limiting portion 913 and the second limiting portion 914 to constrain the first limiting portion 913 and the second limiting portion 914 to separate from each other, so that the first limiting portion 913 and the second limiting portion 914 can limit the target segment 601 in the radial direction, thereby achieving radial limiting of the target segment 601; when the stent graft 100 is in the second state, the constraint member 92 can be separated from the first limiting portion 913 and the second limiting portion 914, so that the first limiting portion 913 and the second limiting portion 914 release the restriction on the target segment 601, so as to ensure that the sheath core 600 can be smoothly evacuated from the target cavity. The limiting member 91 of this structure is simple in structure, and the radial limiting and releasing operations of the target segment 601 are easy and fast. In this embodiment, the stopper 91 is located in the groove 5, and the sheath core 600 is inserted into the inner cavity of the main stent 10. When in the first state, the stopper 91 limits the target segment 601 through the bottom coating 51a. When in the second state, the stopper 91 is still retained in the groove 5. Even if the stopper 91 is not connected to the groove bottom 51, the groove bottom 51 and the mesh cover 61 can well limit the stopper 91 in the groove 5 to prevent the stopper 91 from escaping from the coated stent 100. In other embodiments, the stopper 91 can be connected to the groove bottom 51, and it can be set in the groove 5 or in the inner cavity of the main stent 10. In other embodiments, the stopper 91 can be made of a degradable material such as polylactic acid, which can be degraded in the body and can promote the rapid thrombosis of the groove 5 to improve the endothelialization process of the coated stent 100.
[0123] See also Figures 18 to 20(A), in some embodiments, the first limiting portion 913 includes a first connecting sub-portion 9131 and a first limiting sub-portion 9132 connected to the first connecting sub-portion 9131, and the second limiting portion 914 includes a second connecting sub-portion 9141 and a second limiting sub-portion 9142 connected to the second connecting portion; when the covered stent 100 is in the first state, the restraining member 92 can pass through the first connecting sub-portion 9131 and the second connecting sub-portion 9141, so that the first limiting sub-portion 9132 and the second limiting sub-portion 9142 can radially limit the target segment 601, thereby realizing the radial restraint of the target segment 601; when the covered stent 100 is in the second state, the restraining member 92 can disengage from the first connecting sub-portion 9131 and the second connecting sub-portion 9141, so that the first connecting sub-portion 9131 and the second connecting sub-portion 9141 move away from each other, and further the first limiting sub-portion 9132 and the second limiting sub-portion 9142 release the restriction on the target segment 601 to ensure that the sheath core 600 can be smoothly withdrawn from the target cavity. Exemplarily, the first connecting sub-portion 9131 is provided with a first connecting hole 91311, and the second connecting sub-portion 9141 is provided with a second connecting hole 91411. When the covered stent 100 is in the first state, the restraining member 92 can pass through the first connecting hole 91311 and the second connecting hole 91411, thereby restraining the first limiting portion 913 and the second limiting portion 914, so that the first limiting sub-portion 9132 and the second limiting sub-portion 9142 can form a limiting space 915 for radially limiting the target segment 601, and the width of the opening 9151 of the limiting space 915 is smaller than the diameter of the sheath core 600. The first connecting hole 91311 and the second connecting hole 91411 are arranged along the axial direction of the groove 5 to form a channel for the restraining member 92 to pass through. The first connecting hole 91311 and the second connecting hole 91411 can be coaxially arranged or non-coaxially arranged, as long as the formed channel can allow the restraining member 92 to pass through, and when the restraining member 92 passes through the channel, the width of the opening 9151 of the limiting space 915 can always be smaller than the diameter of the sheath core 600. It can be understood that the first limiting sub-portion 9132 and the second limiting sub-portion 9142 can be connected to the bottom film 51a or not connected to the bottom film 51a.
[0124] Please refer to Figure 18 , in some embodiments, the first limiting portion 913 and the second limiting portion 914 can be used to cooperate to form a limiting space 915, and at least one of the first limiting portion 913 and the second limiting portion 914 is provided with a limiting portion 916 for restricting the increase of the opening 9151 of the limiting space 915; or, at least one of the first limiting portion 913 and the second limiting portion 914 is provided with a limiting portion 916 for restricting the increase and decrease of the opening 9151 of the limiting space 915, so as to ensure that when the covered stent 100 is in the first state, the first limiting portion 913 and the second limiting portion 914 can realize the radial limiting of the target segment 601 under the restraint of the restraining member 92.
[0125] In some embodiments, the limiting portion 916 can also be used to limit the reduction of the opening 9151 of the limiting space 915, so that the first limiting portion 913 and the second limiting portion 914 cooperate to form a limiting space 915 adapted to the diameter of the target segment 601 of the sheath core 600, reducing the damage to the sheath core 600 by the first limiting portion 913 and / or the second limiting portion 914.
[0126] Please refer to Figures 18 to 20(B) , in some embodiments, the limiting portion 916 includes a first limiting mechanism 916a, and the first limiting mechanism 916a is used to limit the increase of the opening 9151 of the limiting space 915. Exemplarily, the first limiting mechanism 916a includes a first limiting wall 9162 (for example, extending in the transverse direction, that is, the direction from the first limiting sub-portion 9132 to the second limiting sub-portion 9142, or the direction from the second limiting sub-portion 9142 to the first limiting sub-portion 9132) and a second limiting wall 9161 (for example, extending in the longitudinal direction, that is, the direction from the first connection hole 91311 or the second connection hole 91411 to the limiting space 915, or the direction from the limiting space 915 to the first connection hole 91311 or the second connection hole 91411). The second limiting wall 9161 and the first limiting wall 9162 are provided on the first limiting portion 913. The second limiting portion 914 includes a first mating wall 9144 (for example, extending in the transverse direction) and a second mating wall 9143 (for example, extending in the longitudinal direction). The second limiting wall 9161 can abut against the second mating wall 9143 to limit the rotation of the second limiting portion 914 relative to the first limiting portion 913 in the first rotation direction, so as to limit the reduction of the opening 9151 of the limiting space 915. The first limiting wall 9162 can contact the first mating wall 9144 to limit the rotation of the second limiting portion 914 relative to the first limiting portion 913 in the second rotation direction opposite to the first rotation direction to limit the increase of the opening 9151 of the limiting space 915. Thus, when the film-covered stent 100 is in the first state, the restraining member 92 can restrain the positions of the first limiting portion 913 and the second limiting portion 914. The first limiting mechanism 916a can limit the rotation of the second limiting portion 914 between the second limiting wall 9161 and the first limiting wall 9162 in the direction opposite to the clamping direction, thereby playing a role in limiting the increase of the opening 9151 of the limiting space 915, so that the limiting structure 9 can reliably radially limit the sheath core 600. In other embodiments, the second limiting wall 9161 can be omitted.
[0127] Please refer to Figure 19, in some embodiments, the limiting portion 916 and the connecting sub-portion enclose an avoidance space 917 for avoiding the second limiting portion 914. When the constraining member 92 passes through the first limiting portion 913 and the second limiting portion 914, the avoidance space 917 can avoid part of the second limiting portion 914, which is beneficial to reducing the sizes of the first limiting portion 913 and the second limiting portion 914.
[0128] Please refer to Figures 18 to 20(B) , in some embodiments, the limiting portion 916 includes a second limiting mechanism 916b. The second limiting mechanism 916b is at least used to limit the movement of the first limiting portion 913 and the second limiting portion 914 along the length extension direction of the constraining member 92. Exemplarily, the second limiting mechanism 916b is also used to limit the increase of the opening 9151 of the limiting space 915. The second limiting mechanism 916b further includes a constraining groove 9163, and the constraining groove 9163 is provided in one of the first connecting sub-portion 9131 and the second connecting sub-portion 9141, and the other of the first connecting sub-portion 9131 and the second connecting sub-portion 9141 can be inserted into the constraining groove 9163 to at least limit the movement of the first limiting portion 913 and the second limiting portion 914 along the length extension direction of the constraining member 92. For example, the constraining groove 9163 is provided in the second connecting sub-portion 9141, and the first connecting sub-portion 9131 can be inserted into the constraining groove 9163, so that the two opposite groove walls of the constraining groove 9163 limit the first connecting sub-portion 9131 along the length direction of the constraining member 92, thereby realizing the limitation of the first limiting portion 913 and the second limiting portion 914 along the length extension direction of the constraining member 92. A third limiting wall 9164 (for example, extending horizontally) and a fourth limiting wall 9165 (for example, extending longitudinally) are provided in the constraining groove 9163. The first limiting portion 913 includes a third mating wall 9145 (for example, extending horizontally) and a fourth mating wall 9146 (for example, extending longitudinally). The fourth limiting wall 9165 can abut against the fourth mating wall 9146 to limit the rotation of the second limiting portion 914 relative to the first limiting portion 913 in the first rotation direction, so as to limit the reduction of the opening 9151 of the limiting space 915. The third limiting wall 9164 can abut against the third mating wall 9145 to limit the rotation of the second limiting portion 914 relative to the first limiting portion 913 in the second rotation direction opposite to the first rotation direction to limit the increase of the opening 9151 of the limiting space 915. In other embodiments, the fourth limiting wall 9165 can be omitted. In other embodiments, one of the first limiting mechanism 916a and the second limiting mechanism 916b can be omitted. In other embodiments, the number of the first limiting mechanism 916a and the second limiting mechanism 916b can be one or more.
[0129] Please refer to Figure 18 , in combination with Figure 15, in some embodiments, the edges of the first branch opening 811 of the first branch stent 81 and the second branch opening 821 of the second branch stent 82 connected to the bottom of the groove 51 form a raised clearance 54 that bulges upward. The portion of the limiting structure 9 for connecting with the restraint 92 is axially opposite to the raised clearance 54. For example, the wire buckling portion 912 is axially opposite to the raised clearance 54. Another example is that the limiting space 915 is axially opposite to the raised clearance 54, which is beneficial to improving the radial limiting effect on the sheath core 600.
[0130] Please refer to Figure 21 and Figure 22 , in some embodiments, the covered stent 100 includes the main stent 10, the limiting channel 62 and two inner branch stents 8 of any one of the above embodiments, which are respectively denoted as the first branch stent 81 and the second branch stent 82. The first branch stent 81 and the second branch stent 82 are arranged side by side in the radial direction within the main stent 10. The first branch stent 81 is provided with a first branch opening 811 at one end closer to the groove 5, and the second branch stent 82 is provided with a second branch opening 821 at one end closer to the groove 5. The first branch opening 811 and the second branch opening 821 both face the groove 5, and the first branch opening 811 and the second branch opening 821 are both communicated with the groove 5; the limiting channel 62 is formed between the first branch stent 81 and the second branch stent 82, and the limiting channel 62 is used to limit the sheath core 600 in the radial direction.
[0131] For the covered stent 100 of the above embodiments, in actual application, the covered stent 100 can be first compressed and assembled on a conveyor (such as a delivery sheath). Before the covered stent 100 is released and detached from the conveyor, the sheath core 600 passes through the limiting channel 62, and the limiting channel 62 can radially limit the sheath core 600. When the covered stent 100 needs to be implanted into the target cavity, the covered stent 100 is implanted into the target cavity through the conveyor; when the covered stent 100 located in the target cavity is released and expanded from the conveyor, the sheath core 600 of the conveyor abuts against the supra-aortic region 301 of the aortic arch 300, and the covered stent 100 expands in a direction away from the sheath core 600. Since the limiting channel 62 can radially limit the sheath core 600 before the covered stent 100 is fully expanded, the probability of the sheath core 600 deviating relative to the groove 5 can be reduced, so that the groove 5 of the covered stent 100 can be more accurately aligned with the branch blood vessel 200 after implantation, reducing the probability of the covered stent 100 blocking or occluding the branch blood vessel 200, and thus ensuring that the blood flow in the branch blood vessel 200 can flow normally and smoothly, and reducing the complications caused by poor blood flow. After the covered stent 100 is implanted into the target cavity and released from the conveyor, the sheath core 600 can be withdrawn axially from the target cavity.
[0132] Please refer to Figure 23, in some embodiments, the first branch stent 81 and the second branch stent 82 are arranged at a radial interval to form a limiting channel 62, and the limiting channel 62 communicates with the inner cavity of the main stent 10 and the groove 5 respectively. In the covered stent 100 of this embodiment, a part of the first branch stent 81, a part of the second branch stent 82, and a part of the main stent 10 jointly enclose to form the limiting channel 62. The structure of the limiting channel 62 for radially limiting the sheath core 600 is simple, reasonable, and ingenious, without the need to additionally provide a limiting structure for radially limiting the sheath core 600, reducing the number of component settings.
[0133] Please refer to Figure 24 and Figure 25 , in some embodiments, the first branch stent 81 is provided with a blank film (denoted as the first blank film 813), the second branch stent 82 is provided with a blank film (denoted as the second blank film 822), and the first blank film 813 and the second blank film 822 are arranged side by side in the radial direction to form a limiting channel 62 between the first branch stent 81 and the second branch stent 82. The first blank film 813 and the second blank film 822 can move away from each other to make the limiting channel 62 in an open state, as Figure 24 shown; when a part of the outer branch stent 500 is implanted into the first branch stent 81 and / or the second branch stent 82 and the sheath core 600 does not pass through the limiting channel 62, the first blank film 813 and the second blank film 822 are attached to make the limiting channel 62 in a closed state, as Figure 25 shown. It can be understood that the first blank film 813 and the second blank film 822 refer to films without support structures such as corrugated rings or waveform units to support them. The radial support capabilities of the first blank film 813 and the second blank film 822 are small, including that the limiting channel 62 formed by the first blank film 813 and the second blank film 822 has good deformability. The limiting channel 62 can open when the sheath core 600 enters the limiting channel 62, and the limiting channel 62 can close when the sheath core 600 does not pass through the limiting channel 62 and a part of the outer branch stent 500 is implanted into the first branch stent 81 and / or the second branch stent 82, so as to prevent the blood in the inner cavity of the main stent 10 from leaking out through the limiting channel 62. In other embodiments, waveform units can also be provided for support in the regions corresponding to the first blank film 813 and the second blank film 822.
[0134] Please refer to Figure 22 and Figure 24, in some embodiments, the first blank film 813 and the second blank film 822 respectively form the first channel wall and the second channel wall of the limiting channel 62. The first channel wall has a first wall edge 8131 and a second wall edge 8132 arranged at intervals in the circumferential direction. The second channel wall has a third wall edge 8221 and a fourth wall edge 8222 arranged at intervals in the circumferential direction. The first wall edge 8131 and the third wall edge 8221 are arranged at intervals and can form an open opening 63. The second wall edge 8132 is connected to the fourth wall edge 8222. The open opening 63 communicates with the limiting channel 62. The setting of the open opening 63 facilitates the insertion of the Tip head 610 (or called the end) of the sheath core 600 into the limiting channel 62 or the withdrawal from the limiting channel 62. It can be understood that the channel wall of the limiting channel 62 can wrap the sheath core 600 with a circumference exceeding 1 / 5. For example, the channel wall of the limiting channel 62 can wrap the sheath core 600 with a circumference exceeding half, so that the limiting channel 62 can better limit the sheath core 600 in the radial direction. Another example is that the channel wall of the limiting channel 62 can wrap the sheath core 600 for one week to better radially limit the sheath core 600. Exemplarily, the main body bracket 10 includes an inner wall section 13 arranged opposite to the open opening 63. The inner wall section 13, the open opening 63 and the second wall edge 8132 are arranged in sequence. The inner wall section 13, the first channel wall and the second channel wall cooperate to form the limiting channel 62. In this way, the requirement for the deformation ability of the first channel wall and the second channel wall can be reduced, so that both the first branch bracket 81 and the second branch bracket 82 can maintain a good shape, so as to have enough space for blood to flow through. In addition, the inner wall section 13, the first channel wall and the second channel wall cooperate to form the limiting channel 62. Compared with the scheme in which the first wall edge 8131 and the third wall edge 8221 are fixedly connected to each other without setting the open opening 63, when the sheath core 600 withdraws from the limiting channel 62, the sheath core 600 abuts against the inner wall section 13 and withdraws, so that the Tip head 610 of the sheath core 600 is not easily hooked on the edge of the opening at the axial end of the limiting channel 62 farther away from the groove 5, and further the corresponding area of the first branch bracket 81 and / or the second branch bracket 82 is not easily deformed or displaced.
[0135] Please refer to Figure 26 and 27, in some embodiments, the first blank film 813 and the second blank film 822 respectively form the first channel wall and the second channel wall of the limiting channel 62. The first channel wall has a first wall edge 8131 and a second wall edge 8132 arranged at intervals in the radial direction. The second channel wall has a third wall edge 8221 and a fourth wall edge 8222 arranged at intervals in the radial direction. The first wall edge 8131 is connected to the third wall edge 8221, and the second wall edge 8132 is connected to the fourth wall edge 8222, so that the channel wall of the limiting channel 62 forms a closed annular structure. The first blank film 813 and the second blank film 822 can move away from each other to open the limiting channel 62 for the sheath core 600 to enter the limiting channel 62, as Figure 26 shown; when the sheath core 600 is withdrawn from the limiting channel 62, the first blank film 813 and the second blank film 822 are attached to each other to close the limiting channel 62. When a part of the outer branch stent 500 is implanted into the first branch stent 81 and / or the second branch stent 82, the first blank film 813 and the second blank film 822 are attached more closely, as Figure 27 shown. When the limiting channel 62 is in a closed state, the attachment of the first blank film 813 and the second blank film 822 can effectively seal the limiting channel 62 to prevent blood from leaking out through the limiting channel 62.
[0136] Please refer to Figure 28 and Figure 29 , in some embodiments, an end support 64 is provided at the opening of the limiting channel 62 at the axial end farther from the groove 5. The end support 64 extends circumferentially along the limiting channel 62; when the inner branch stent 8 is in a natural state, the opening at the axial end of the limiting channel 62 farther from the groove 5 is open; when a part of the outer branch stent 500 is implanted into the inner branch stent 8, the opening at the axial end of the limiting channel 62 farther from the groove 5 is closed, which can prevent the blood flow in the main stent 10 from leaking out through the limiting channel 62. The setting of the end support 64 enables the opening at the axial end of the limiting channel 62 farther from the groove 5 to maintain a good shape and remain open when the inner branch stent 8 is in a natural state (i.e., the state when the outer branch stent 500 is not inserted into the inner branch stent 8 or the inner branch stent 8 is not squeezed and deformed), which is convenient for the sheath core 600 to be withdrawn, and can effectively reduce the risk of the sheath core 600 hooking the opening edge at the axial end of the inner branch stent 8 farther from the groove 5 during the withdrawal process. Exemplarily, the end support 64 includes a corrugated ring, a corrugated unit or other closed or non-closed annular support structures. Exemplarily, the radial support force of the end support 64 is less than the radial support force of the first branch stent 81 or the second branch stent 82. Exemplarily, the end support 64 extends circumferentially along the limiting channel 62 for at least one week, as Figure 28as shown; or, the length of the end support member 64 extending along the circumferential direction of the limit channel 62 is less than the circumference of the limit channel 62, as Figure 29 shown. Exemplarily, the shape of the end support member 64 can be designed into any suitable shape according to actual requirements, such as circular, C-shaped, crescent-shaped, etc. Exemplarily, the end support member 64 can be made of a radiopaque material, which can not only provide a supporting function but also be radiopaque during the operation to better indicate the position of the opening at the axial end of the limit channel 62 that is farther away from the groove 5.
[0137] In some embodiments, the channel wall at the opening at the axial end of the limit channel 62 that is farther away from the groove 5 and / or at the distal opening at the axial end of the limit channel 62 that is closer to the groove 5 is a blank end film. In this embodiment, an end support member is provided at the opening at the axial end of the limit channel 62 that is farther away from the groove 5, and the channel wall at the opening at the axial end of the limit channel 62 that is closer to the groove 5 is a blank end film, that is, no end support member is provided at the opening at the axial end of the limit channel 62 that is closer to the groove 5, so as to prevent the guide wire or the outer branch stent 500 from accidentally entering the limit channel 62 when the covered stent 100 is in the natural state.
[0138] In some embodiments, the sheath core 600 includes a Tip head 610 and a core rod 620 connected to the Tip. To make the sheath core 600 retract more smoothly and reduce the risk of the sheath core 600 hooking on the opening at the axial end of the inner branch stent 8 that is farther away from the groove 5 during the retraction process of the sheath core 600, a transition portion 630 can be provided between the Tip head 610 and the core rod 620 of the sheath core 600. The maximum width of the transition portion 630 gradually decreases from the core rod 620 to the direction of the Tip head 610. Such a setting is beneficial for a smooth transition between the Tip head 610 and the core rod 620, and can make the sheath core 600 retract more smoothly from the limit channel 62.
[0139] In some embodiments, the limit channel 62 and the bottom film-covered section 511 are axially spaced apart, so that the limit groove 512 formed by the limit channel 62 and the bottom film-covered section 511 is axially spaced apart. In this way, both the limit channel 62 and the limit groove 512 can radially limit the sheath core 600, improving the radial limiting ability of the sheath core 600.
[0140] In some embodiments, the limit channel 62 and the limit structure 9 are axially spaced apart, so that the limit channel 62 and the limit structure 9 are axially spaced apart. In this way, both the limit channel 62 and the limit structure 9 can radially limit the sheath core 600, improving the radial limiting ability of the sheath core 600.
[0141] In some embodiments, the limit structure 9 and the bottom film-covered section 511 can respectively radially limit the sheath core 600, improving the radial limiting ability of the sheath core 600.
[0142] In some embodiments, the limiting channel 62 and the bottom film covering section 511 are arranged at an axial interval so that the limiting groove 512 formed by the limiting channel 62 and the bottom film covering section 511 is arranged at an axial interval; the limiting structure 9 and the bottom film covering section 511 can respectively perform radial limiting on the sheath core 600; thus, the limiting channel 62, the limiting groove 512, and the limiting structure 9 can all perform radial limiting on the sheath core 600, effectively improving the radial limiting ability of the sheath core 600.
[0143] It can be understood that any one of the above-mentioned bottom film covering section 511, limiting structure 9, and limiting channel 62 can be provided, or any two of the three can be provided, or all three can be provided at the same time.
[0144] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "installation", "connection", "connection", "mechanical coupling", and "coupling" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components or the interaction relationship between two components. The mechanical coupling or coupling of two components includes direct coupling and indirect coupling. For example, direct fixed connection, connection through a transmission mechanism, etc. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.
[0145] In the present invention, unless otherwise clearly specified and defined, the first feature being "above" or "below" the second feature may include the first and second features being in direct contact, or may include the first and second features not being in direct contact but being in contact through other features therebetween. Moreover, the first feature being "above", "above", and "on" the second feature includes the first feature being directly above and obliquely above the second feature, or merely indicating that the first feature is at a higher horizontal height than the second feature. The first feature being "below", "below", and "under" the second feature includes the first feature being directly below and obliquely below the second feature, or merely indicating that the first feature is at a lower horizontal height than the second feature.
[0146] As described above, only the specific embodiments of the present invention are provided, but the protection scope of the present invention is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present invention can easily think of various equivalent modifications or substitutions, and these modifications or substitutions should all be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.
Claims
1. A covered stent, characterized in that, Comprising: A main body bracket, provided with a groove, the bottom of the groove includes a bottom film; A support structure, including a bottom support member for supporting the bottom film; Wherein, the bottom support member includes two support portions spaced along the width direction of the groove, the bottom film includes a blank bottom film section located between the two support portions along the width direction of the groove; the two support portions can move relative to each other so that the bottom film section can be deformed.
2. The covered stent according to claim 1, characterized in that, The two support portions can move relative to each other so that the bottom film section can be deformed to form a limiting groove for axially limiting the sheath core, the extension dimension of the bottom film section in the width direction of the groove is greater than half of the circumference of the sheath core, and the extension dimension of the bottom film section in the width direction of the groove is greater than or less than the circumference of the sheath core.
3. The covered stent according to claim 1, characterized in that, The film bracket includes a plurality of bottom support members arranged in sequence axially, namely a first bottom support member, a second bottom support member and a third bottom support member; at least two of the first bottom support member, the second bottom support member and the third bottom support member respectively correspond to include two support portions and a bottom film section.
4. The covered stent according to claim 1, characterized in that, The film bracket includes two inner branch brackets arranged side by side radially within the main body bracket, namely a first branch bracket and a second branch bracket, one end of the first branch bracket facing the groove is provided with a first branch opening, one end of the second branch bracket facing the groove is provided with a second branch opening, the edges of the first branch opening and the second branch opening connected to the bottom of the groove form a raised gap bulging upward, and the bottom film section and the raised gap are axially opposite.
5. The covered stent according to claim 1, characterized in that, The bottom film section axially penetrates the bottom support member.
6. The covered stent according to claim 1, wherein The bottom support member further includes: A connecting portion, the connecting portion is respectively connected to the two support portions, one of the support portions and the other support portion are arranged side by side along the width direction of the groove to form a spaced space, the area of the bottom film corresponding to the spaced space is the bottom film section, the connecting portion and the bottom film section are arranged axially, and the connecting portion is closer to the axial end of the bottom film than the bottom film section.
7. The covered stent according to claim 6, wherein The film bracket includes: a movable connection between the connecting portion and the support portion, and the movable connection includes one or more of a hooking connection, a hinge connection, and a connection through an elastic member.
8. The covered stent according to claim 6, wherein The support portion includes a plurality of support sub-units arranged in sequence along the width direction of the groove, and the support sub-unit closest to the bottom film section in the support portion is indirectly connected to the connecting portion.
9. The covered stent according to claim 1, wherein The film bracket further includes an inner branch bracket provided within the main body bracket, the inner branch bracket communicates the inner cavity of the main body bracket and the groove, and at least one inner branch bracket is provided on one axial side of the groove; the bottom support member located at the axial end of the bottom of the groove includes a width reduction section, and the width of the width reduction section becomes smaller along the direction close to the inner branch bracket.
10. The covered stent according to claim 1, characterized in that, The support portion includes: A mesh structure, including a first radially side edge and a second radially side edge spaced apart along the width direction of the groove, the first radially side edge being closer to the bottom film section than the second radially side edge; A support unit, extending axially and connected to the first radially side edge of the mesh structure; A deformable buffer unit, connected to the second radially side edge of the mesh structure.
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